FDA Approves Fulvestrant/Abemaciclib Combination for Breast Cancer

The approval was based on results from the phase 3 MONARCH 2 trial, for which patients were randomly assigned to receive fulvestrant plus abemaciclib or fulvestrant plus placebo.

The US Food and Drug Administration (FDA) approved fulvestrant with abemaciclib for patients with hormone receptor–positive, HER2-negative advanced or metastatic breast cancer, according to a press release.1 Patients who progress on endocrine therapy are eligible for the combination.

The approval was based on results from the phase 3 MONARCH 2 trial (ClinicalTrials.gov Identifier: NCT02107703), for which patients were randomly assigned to receive fulvestrant plus abemaciclib (446 patients) or fulvestrant plus placebo (223 patients).2 Patients in the abemaciclib group had double the objective response rate of those in the placebo group (48.1% vs 21.3%, respectively) and more than a 7-month improvement in progression-free survival (16.4 months vs 9.3 months).

Some adverse events were, however, much more common in the abemaciclib arm, including diarrhea, neutropenia, nausea, and fatigue.

Abemaciclib is a CDK4/6 inhibitor that was granted Breakthrough Designation by the FDA in 2015. It was approved in September 2017 for patients with hormone receptor–positive, HER2-negative breast cancer previously treated with hormone therapy.

Fulvestrant is an estrogen-targeting therapy that was approved for some patients with breast cancer in 2002.

More in Breast Cancer

1. In women both with and without personal history of breast cancer (PHBC), screening MRI was associated with higher biopsy rates compared to mammography. 2. Screening MRI was also associated with lower rates of ductal carcinoma in situ (DCIS) and invasive cancer findings when compared ...

CancerTherapyAdvisor.com is a free online resource that offers oncology healthcare professionals a comprehensive knowledge base of practical oncology information and clinical tools to assist in making the right decisions for their patients.

Our mission is to provide practice-focused clinical and drug information that is reflective of current and emerging principles of care that will help to inform oncology decisions.